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CCN-2013-4

Stress simplified by design Rapiscan is the only standard dose, infusion pump-free, selective coronary vasodilator for use as a pharmacological stress agent for radionuclide myocardial perfusion imaging. Administer Rapiscan as a full 10 sec IV injection Flush immediately with 5ml saline Deliver radiotracer 10-20 seconds after saline flush Now this won’t take a minute... Rapiscan is the only standard dose, infusion pump-free, selective coronary vasodilator for use as a pharmacological stress agent for radionuclide myocardial perfusion imaging. Administer Rapiscan as a full 10 sec IV injection Flush immediately with 5ml saline Deliver radiotracer 10-20 seconds after saline flush For more information please visit www.rapiscan-mpi.com In Germany, Rapiscan is distributed by GE Healthcare PRESCRIBERS SHOULD READ THE SUMMARY OF PRODUCT CHARACTERISTICS (SPC) Rapiscan vials contain regadenoson (400 microgram solution for injection). Indication: Pharmacological stress agent for radionuclide myocardial perfusion imaging in adult patients. Dosage and Administration: Each 5 mL vial contains 400 micrograms regadenoson, which is injected over 10 seconds into a peripheral vein followed by 5 mL saline (0.9% sodium chloride) solution flush. The radiopharmaceutical should be administered 10-20 seconds after saline injection. The same catheter may be used for Rapiscan and the radiopharmaceutical. Patients should avoid consumption of any products containing methylxanthines (e.g. caffeine) as well as any medicinal products containing theophylline for at least 12 hours before Rapiscan administration. When possible, dipyridamole shouldbewithheldforatleasttwodayspriortoRapiscanadministration. Contra-indications: Hypersensitivity to active substance or excipients; patients with second or third degree AV block or sinus node dysfunction who do not have a functioning artificial pacemaker; unstable angina that has not been stabilised with medical therapy; severe hypotension; decompensatedheartfailure.Precautions:Rapiscanhasthepotentialto causeseriousandlife-threateningreactions.ContinuousECGmonitoring should be performed and vital signs monitored at frequent intervals until ECG parameters, heart rate and blood pressure have returned to pre-dose levels. Aminophylline may be administered by slow intravenous injection to attenuate severe and/or persistent adverse reactions to Rapiscan. Fatal cardiac arrest, life-threatening ventricular arrhythmias, and myocardial infarction may result from the ischaemia induced by pharmacologic stress agents like regadenoson. Adenosine receptoragonistsincludingregadenosoncandepressthesinoatrial(SA) and AV nodes and may cause first, second or third degree AV block, or sinus bradycardia. Adenosine receptor agonists including regadenoson induce arterial vasodilation and hypotension. The risk of serious hypotension may be higher in patients with autonomic dysfunction, hypovolemia, left main coronary artery stenosis, stenotic valvular heart disease, pericarditis or pericardial effusions, or stenotic carotid artery disease with cerebrovascular insufficiency. Adenosine receptor agonists may cause bronchoconstriction and respiratory compromise. For patients with known or suspected bronchoconstrictive disease, chronic obstructive pulmonary disease (COPD) or asthma, appropriate bronchodilator therapy and resuscitative measures should be available prior to Rapiscan administration. Regadenoson stimulates sympathetic output and may increase the risk of ventricular tachyarrhythmias in patients with a long QT syndrome. This medicinal product contains less than 1 mmol sodium (23 mg) per dose. However, the injection of sodium chloride 9 mg/ml (0.9%) solution given after Rapiscan contains 45 mg of sodium. To be taken into consideration by patients on a controlled sodium diet. Undesirable effects: Adverse reactions in most patients were mild, transient (usually resolving within 30 minutes) and required no medical intervention. Rapiscan may cause myocardial ischaemia, hypotension leading to syncope and transient ischaemic attacks, and SA/AV node block requiring intervention. Aminophylline may be used to attenuate severe or persistent adverse reactions. Very common adverse events reported were dyspnoea, headache, flushing, chest pain, electrocardiogram ST changes, gastrointestinal discomfort, and dizziness. Common adverse events reported were paraesthesia, hypoaesthesia, dysgeusia, angina pectoris, atrioventricular block, tachycardia, palpitations, other ECG abnormalities including electrocardiogram QT corrected interval prolonged, hypotension, throat tightness, throat irritation, cough, vomiting, nausea, oral discomfort, back, neck or jaw pain, pain in extremity, musculoskeletal discomfort, hyperhidrosis, malaise, and asthenia. See SPC for details of other undesirable effects. Presentation: One carton contains a single vial of Rapiscan (400 micrograms regadenoson in 5mL solution for injection). Price: Please see your local distributor. ATC code: C01EB21. Legal Classification: POM. Marketing authorization holder: Rapidscan Pharma Solutions EU Ltd, Regent’s Place, 338 Euston Road, London, NW1 3BT, United Kingdom. Marketing authorization number: EU/1/10/643/001 Date of preparation: April 2012. Adverse events should be reported to your local regulatory authority. Please contact your local distributor for reporting forms or email safety@rapiscan-mpi.com. In the UK: Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported by phone 080 0652 1391, fax 080 0471 5035, or email safety@rapiscan-mpi.com. [Rapidscan Pharma Solutions EU Ltd] RAPISCAN® (regadenoson) ABBREVIATED PRESCRIBING INFORMATION Rapiscan is a registered trademark of Rapiscan Pharma Solutions EU Ltd @2012 Rapiscan Pharma Solutions EU Ltd. All rights reserved RPS EU 12-010 Date of preparation: June 2012 RPS EU 12-009

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